Zai Lab’s ZL-1310 Receives FDA Fast Track Designation for Small Cell Lung Cancer
Monday, May 19, 2025
Zai Lab Limited has announced that its investigational therapy ZL-1310 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of extensive-stage small cell lung cancer (ES-SCLC).
Small Cell Lung Cancer (SCLC) is a fast-growing type of lung cancer that typically starts in the breathing tubes (bronchi) and quickly spreads to other parts of the body. It accounts for about 10–15% of all lung cancer cases and is strongly linked to smoking. SCLC is usually classified into two stages: limited-stage (confined to one side of the chest) and extensive-stage (spread widely in the lungs or to other organs).
ZL-1310 is a potential first-in-class antibody-drug conjugate (ADC) that targets Delta-like ligand 3 (DLL3), a protein commonly expressed in small cell lung cancer. The treatment is currently being assessed in a global Phase 1a/1b clinical trial (NCT06179069). It had previously received Orphan Drug designation from the FDA for small cell lung cancer.
The Fast Track status is intended to support the development of treatments that address serious or life-threatening conditions with unmet medical needs. This designation allows for closer interaction with the FDA throughout the development process and may lead to benefits such as Accelerated Approval and Priority Review if certain conditions are met.
Zai Lab is expected to present updated clinical trial data at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The company also plans to begin a pivotal study later in 2025, with the aim of pursuing accelerated approval by 2027.
Source: zailaboratory.com
